FDA UDI
In Commercial Distribution
🇺🇸 United States
ARK™ Levetiracetam Assay
DI: 00858724003032
·
Model: 5024-0001-00
·
ARK DIAGNOSTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ARK™ Levetiracetam Assay
- Primary DI
- 00858724003032
- Version / Model
- 5024-0001-00
- Catalog Number
- 5024-0001-00
- Company Name
- ARK DIAGNOSTICS INC
- Labeler DUNS
- 164880598
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2020-01-09
- Public Version Status
- Update
- Public Device Record Key
- bf78a5e1-45ce-4a88-8fea-da0fb464e670
Device Description
The ARK™ Levetiracetam Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Levetiracetam in human serum or plasma on automated clinical chemistry analyzers. Levetiracetam concentrations can be used as an aid in management of patients treated with Levetiracetam. The ARK™ Levetiracetam Assay consists of reagents RI anti-Levetiracetam polyclonal antibody with substrate and R2 Levetiracetam epitope labeled with bacterial G6PDH enzyme.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ORI | Levetiracetam Assay | Clinical Toxicology | 862.3350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55674 | Levetiracetam therapeutic drug monitoring IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement and therapeutic monitoring of the central nervous system drug levetiracetam (e.g., Keppra) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858724003032 | GS1 |
Customer Contacts
- Phone
- 5102706270
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091653 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius